Diagnosing and Treating UTIs: DNA PCR vs. Urine Culture

This study is comparing two ways to diagnose urinary tract infections (UTIs): DNA PCR (a gene analysis test) and standard urine culture. Researchers want to see which method better helps improve your UTI symptoms. You may be able to join if you are an adult (18 or older) experiencing UTI symptoms and have Medicare or Medicaid insurance. You cannot join if you've had a recent UTI or antibiotic treatment. The study will measure how much your symptoms change using two questionnaires, completed at the start and again one day after you finish any prescribed antibiotics. The study status is unclear, and it plans to enroll 136 participants.

Study design
This interventional study will randomly assign 136 adult participants to either the DNA PCR or urine culture group. The study phase is not specified.
What's involved
You will complete two questionnaires at the start of the study. If you receive antibiotics for a UTI, you will complete the questionnaires again one day after finishing them. Your participation will last a maximum of 21 days.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up one day after completing antibiotic treatment to assess symptom changes.

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NCT06808451

Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture

Recruiting
NAAges 18+InterventionalDiagnostic
University Hospitals Cleveland Medical Center
~136 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:DNA PCRUrine Culture

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in symptoms as measured by UTI-SIQ-8 questionnaire
Measured over Baseline, one day after antibiotic completion
+1 more outcome measured
Urinary Tract Infections
1 sites across 1 states
Ohio1
  • David Sheyn, MD · PRINCIPAL_INVESTIGATOR · University Hospitals

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult men and women 18 years and older
Presenting to clinic with symptoms of UTI or cystitis
Patients with Medicare and Medicaid insurance

Exclusion

Urinary diversion of any type
Chronic indwelling urinary catheter
Diagnosed UTI within the previous 21 days
Antibiotic therapy within the previous 21 days
Use of phenazopyridine within the previous 21 days
Commercial insurance
Non-English speaking
Pregnant patients
  • Change in symptoms as measured by UTI-SIQ-8 questionnaireBaseline, one day after antibiotic completion

    The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.

  • Change in symptoms as measured by the UTI Symptom Assessment questionnaireBaseline, one day after antibiotic completion

    The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.